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Profile: DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoassays & lab equipments. Our enzyme immunoassays include adrenocorticotropic hormone, alpha fetoprotein, anti-nuclear antibodies, atrial natriuretic polypeptide, acylation-stimulating protein, adiponectin rat elisa, neopterin elisa, norepinephrine and vanyl mandelic acid. We offer laboratory equipments such as check strips, microplate reader, incubator, photometer check set, rack tubes, sperm quality analyzer and strip reader.

The company was founded in 1970, has revenues of USD 10-25 Million, has ~100 employees and is ISO 9000, ISO 9001, CE certified.

FDA Registration Number: 2245285

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• Giardia Spp. (FDA Code: MHI / 866.3220)

• Gliadin Antibodies (FDA Code: MST / 866.5750) A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

• Glucagon Radioimmunoassay Test (FDA Code: JME / 862.1335) A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia.

• Goat Antibody Morphine (125-I) Radioimmunoassay Test (FDA Code: DOE / 862.3640) A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

• HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX / 862.1155) A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

• Hemophilus Spp Fluorescent Antisera (FDA Code: GRO / 866.3300)

• Herpes Simplex Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LGC / 866.3305)

• Home pregnancy test kits, Hcg

• Hospital/Nursing Management Computer Software

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)

• Human Growth Hormone Radioimmunoassay (FDA Code: CFL / 862.1370) A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

• IgE Control (FDA Code: DGC / 866.5510) An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660) A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

• Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP / 862.1405) An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.

• Incubator Shakers

• Incubators

• Indirect Immunofluorescent Multiple Auto Antibody (FDA Code: DBL / 866.5660)

• Influenza Virus (A, B, C) Antisera (FDA Code: GNW / 866.3330) Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

• Insulin-Like Growth Factor Binding Protein-1 Immunoassay (FDA Code: OAM / 862.1550) A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

• Intra-Aortic Balloon System (FDA Code: DSP / 870.3535) A intra-aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.

• Lab Equipment

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Laboratory Equipment

• Laboratory Equipment Devices

• Lactoferrin (FDA Code: DEG / 866.5570) A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.

• Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL / 866.3300)

• Leptospira Spp Antigen (FDA Code: GRY / 866.3350)

• Lipoprotein Low-Density Test System (FDA Code: MRR / 862.1475) A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485) A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

• Lyme Disease (Borrelia) Test Kits

• Medical Diagnostic Equipment

• Metamphetamine Thin Layer Chromatography Test (FDA Code: DJC / 862.3610) A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

• Methadone Enzyme Immunoassay Test (FDA Code: DJR / 862.3620) A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

• Methamphetamine Gas Chromatography Test (FDA Code: LAF / 862.3610)

• Monoclonal Antibody Test

• Morphine Fluorometry Test (FDA Code: DJJ / 862.3640)

• Multi-Analyte Controls Unassayed (FDA Code: OHQ / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Mumps Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LJY / 866.3380) Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

• Mycoplasma Spp Enzyme Linked Immunoabsorbent Assay (FDA Code: LJZ / 866.3375)

• Ninhydrin and L-Leucyl-L-Alanine Test (FDA Code: JNB / 862.1555) A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

• Nitrosonaphthol Test for 5-Hydroxyindole Acetic Acid Nitrous Acid (FDA Code: CDA / 862.1390) A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.

• Nocotine And Nicotine Metabolites Enzyme Immunoassasy (FDA Code: MKU / 862.3220) A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

• Nursing Computer Software

• Occult Blood Reagent (FDA Code: KHE / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Opiates Enzyme Immunoassay Test (FDA Code: DJG / 862.3650) An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

• Over The Counter Follicle Stimulating Hormone (Fsh) Test (FDA Code: NGA / 862.1300) A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• P-Nitroaniline/Vanillin Vanilmandelic Acid Diazo Test (FDA Code: CDF / 862.1795) A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

• Parainfluenza Virus 1-4 CF Antisera (FDA Code: GQT / 866.3400) Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.

• Parathyroid Hormone Radioimmunoassay Test (FDA Code: CEW / 862.1545) A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

• Percutaneous Transluminal Coronary Angioplasty Catheter (FDA Code: LOX / 870.5100)